Category - Recast

medicaldeviceslegal

eHealth and mHealth at the DIA Euromeeting

I had the privilege to preside a session about eHealth and mHealth at the DIA Euromeeting in Amsterdam last week, joined by Mr Tapani Piha, Head of Unit for eHealth, Health Technology Assessment and Science of DG SANCO of the European Commission and Mrs Marianne Fournier of Voisin Consulting. In a lively session we took […]

medicaldeviceslegal

Fireworks! Or a disappointing dud? The 26 February ENVI workshop on the EU medical devices and IVD proposals

With the ENVI committee “workshop” on the medical devices regulation and IVD regulation proposals in sight next week, medical devices media have been drumming up momentum by using exciting adjectives like ”fireworks” that make this workshop sound like it will be an ‘epic battle‘, or how about a ‘clash of the titans’? I wouldn’t want to go […]

medicaldeviceslegal

Happy New Year – with all those developments

The end of the year is upon us, and I’d like to take the opportunity to wish the readers of this blog all the best for the new year, a new year with lots of exciting developments ahead. This post will not be the usual regulatory and legal analysis of rules, but something more forward […]

medicaldeviceslegal

Seminar on the new EU proposal on medical devices regulation

Dear readers, while I am working on the promised blog posts on parts of the new regulation proposal for medical devices, I would like to let you know about the two and a half hour afternoon seminar that my firm will organise this 14 November in cooperation with Philips Healthcare and the Qserve Group. As […]

medicaldeviceslegal

New EU medical devices regulations proposals out – first impression: nothing unexpected but devil is in the details

Today was a big day with a half hour press conference by Commissioner Dalli (for Twitter summaries see here and here) to festively launch the two much anticipated EU medical devices regulation proposals (one for general medical devices, including active implantables, and one for IVDs). The generalities of the proposals, as you can read in the press release and the Commission’s communication on the subject, are […]